Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0771-2020 — NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the capt

U.S. FDA — Device Enforcement · United States · 2019-02-25 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0771-2020
Date of alert: 2019-02-25
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Nidek, Inc.
Product category: device
Product type: Devices

Reported risk: The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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